The careHPV test – WHO prequalified, HPV screening test developed for limited resource settings and emerging markets
Cervical cancer is the second most common cancer in the world, and the majority of those who die from cervical cancer are under screened women in developing countries with a healthcare system lacking in infrastructure, funding, access, and skilled personnel (1).
QIAGEN’s careHPV Test was designed with these women in mind. It allows testing for high-risk HPV in limited resource settings and can be used for primary, stand-alone screening in women 30 years and older to determine high-risk HPV infection, which is a risk factor for developing cervical cancer (2).
careHPV resources
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Adaptable and affordable high-risk HPV-test
The careHPV Test can be run by a healthcare worker with proper training and no formal laboratory skills are required. The test may be run on electricity or on a battery with an inverter, making it portable and adaptable. The test can be run in a flexible temperature range, from 15°C to 40°C.
The careHPV Test benefits include:
- Detection of 14 high-risk HPV types
- Convenient test results in 2.5 hours (excluding sample prep) for possible same-day follow up
- Accurate, robust, and accessible primary screening
- High clinical sensitivity and specificity
Accurate and effective test for the detection of high-risk HPV
The careHPV Test is a nucleic acid hybridization assay with signal amplification that uses microplate chemiluminescence for the qualitative detection of 14 high-risk types of HPV DNA in cervical and vaginal specimens. The HPV types detected by the assay are the high-risk HPV DNA types 16,18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68. Individual HPV types cannot be determined using this test. The careHPV Test is CE-marked for use as an in vitro diagnostic test.
Key Benefits of careHPV
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WHO prequalified
careHPV is now a WHO prequalified IVD solution for developing countries — a practical and affordable test that can be used in limited-resource settings. -
Accuracy
careHPV uses Hybrid Capture 2 (HC2) technology to detect the presence of 14 high-risk carcinogenic HPV types. -
Adaptability
careHPV can be run using electricity or a battery with an inverter and requires no external water source, making it portable and adaptable. The test can be run in a flexible temperature range, from 15°C to 40°C. -
Time savings
careHPV allows for sample collection performed using the careBrush and can be taken by properly trained healthcare professional -
Streamlined sample collection
careHPV is a primary screening tool with test results in 2.5 hours. It can potentially reduce the waiting time for follow-up in patients for whom the results indicate a high-risk HPV result.
The careHPV Test is Not Available in the United States.
References
- World Health Organization webpage: http://www.who.int/news-room/fact-sheets/detail/human-papillomavirus-(hpv)-and-cervical-cancer
- careHPV Test Kit Handbook. Version 1. November 2015
The careBrush, careHPV Collection Medium, and the careHPV Test are CE-marked for in vitro diagnostic use. Not available in all countries.
CARE is a registered trademark of COOPERATIVE FOR ASSISTANCE AND RELIEF EVERYWHERE, INC. (“CARE”). CARE and the members and affiliates of CARE International are not affiliated with QIAGEN and do not sponsor, endorse, support, participate in or control the development, manufacture, use or sale of any QIAGEN product.